Low Back Pain (LBP)360° BreathNCT06943898
Investigation of the Acute Effects of Core Stabilization and 360-Degree Breathing Exercises on Balance and Proprioception in Individuals With Non-Specific Low Back Pain
A study testing Core Egzercise and Core Exercises + Breathing Exercises in people with Low Back Pain (LBP) and Exercise, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed as a single-blind randomized controlled trial. Male and female patients aged 18-65 years with complaints of non-specific low back pain (NSLBP) lasting longer than 12 weeks will be included in the study. Participants will be randomly assigned into two parallel groups: control and intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain (LBP), Exercise, Core Stability
- What is being tested?
- Core Egzercise and Core Exercises + Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain persisting for at least 3 months
- No neurological, rheumatological, or musculoskeletal system problems
Who cannot join
- Individuals with neurological, vestibular, or serious orthopedic conditions that may cause physical disability
- Patients with back-leg or dorsolumbar pain due to lumbar disc protrusion or fracture
- Cancer patients
- Individuals with acute infections
- Individuals with respiratory system diseases
- Individuals with any mental disorder that would prevent participation in the study assessment
- Pregnant individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Sivas, Merkez, 58000
Selvin Balki, +905065945067, sbalki@cumhuriyet.edu.tr
About this study
This study is designed as a single-blind randomized controlled trial. Male and female patients aged 18-65 years with complaints of non-specific low back pain (NSLBP) lasting longer than 12 weeks will be included in the study. Participants will be randomly assigned into two parallel groups: control and intervention. The control group will perform core stabilization exercises five days a week for three weeks. In the intervention group, core stabilization exercises will be combined with 360-degree breathing exercises. To our knowledge, there is no randomized controlled trial investigating the effect of combining core stabilization with 360-degree breathing in individuals with NSLBP. The aim of this study is to examine the acute effects of combining 360-degree breathing techniques with core stabilization exercises on balance and proprioception in individuals with NSLBP.
Read the detailed description
Low back pain is a major health problem worldwide. Non-specific low back pain (NSLBP) is the most common form of back pain. The lifetime prevalence of back pain can reach up to 84%. Various non-pharmacological and non-invasive methods are used for back pain management. One such method is core stabilization exercises. Core stabilization exercises enhance trunk stability by activating the muscles around the spine and have the potential to improve balance in individuals with NSLBP. This may help overcome balance disorders associated with pain and contribute to safer movements in daily life activities. Breathing exercises, by activating the diaphragm muscle, support spinal stability and provide benefits in pain management. It is known that breathing supports trunk stability through its relationship with core muscles and strengthens balance mechanisms. Studies in this field show that stabilization exercises can provide short-term improvements, especially in balance. However, the combined effects of core stabilization and breathing exercises in individuals with NSLBP have not been fully investigated. Therefore, this study aims to investigate the acute effects of combining 360-degree breathing exercises with core stabilization exercises on balance and proprioception in individuals with NSLBP.
- Conditions
- Low Back Pain (LBP), Exercise, Core Stability
- Being tested
- Core Egzercise, Core Exercises + Breathing Exercises
- Keywords
- core stability exercise, low back pain, exercise
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core EgzerciseOther
The core exercise group will perform core stabilization exercises for a total of 15 sessions, five days a week for three weeks. Exercises will include pelvic tilt, bridge, dead bug, bird dog, mini squats on a balance board, and wall planks. The number of repetitions will be increased from 10 to 20, and plank duration will be increased from 30 seconds to 45 seconds. A 5-minute warm-up and cool-down session will be included.
Core Exercises + Breathing ExercisesOther
This group will perform core stabilization exercises combined with the 360-degree breathing technique, for a total of 15 sessions over three weeks (five days a week).
"360-degree breathing" is a novel breathing method targeting deep and controlled inhalations into various regions of the body. Unlike traditional breathing exercises, 360-degree breathing ensures that all directions of the lungs are equally ventilated.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Core Exercises) | Other | Core Exercises Group Receives: Other: Core Egzercise |
| Intervention Group (Core Exercises + Breathing Exercises): | Other | Core Exercises + Breathing Exercises Receives: Other: Core Exercises + Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Proprioception Assessment
Proprioception will be evaluated using an inclinometric method. An inclinometer is usually placed and fixed at the L3-L4 segment of the lumbar spine. The patient will be asked to achieve and then reproduce a target position. The difference between the reference angle and the reproduced angle (position error) will be recorded as a measure of proprioceptive perception.
Measured: 3 week
Y Balance Test (YBT)
The Y Balance Test (YBT) will be used to assess balance. Patients will remove their shoes and place the stance foot on the center footplate of the YBT platform. They will attempt to reach maximally with the opposite leg in three directions (anterior, posteromedial, and posterolateral), maintaining balance on the stance leg. Maximum reach distances will be recorded.
Measured: 3 week
Secondary outcomes (2)
Core Muscle Endurance Assessment:
Core endurance will be assessed using McGill's protocol, including trunk extension, trunk flexion, lateral bridge, and prone bridge tests.
- Trunk Extension Test: In the prone position, the trunk is extended off the edge of the table to the level of the anterior superior iliac spine. Upper body is supported by arms on a chair, hips and legs are fixed. After removing the support, the individual crosses their arms over the chest. The time the individual can hold this position is recorded in seconds.
- Trunk Flexion Test: The patient sits on the table with hips and knees at 90° flexion and the trunk at 60° flexion. Feet are secured to the table, arms crossed over the chest. After removing the back support, the individual maintains the position as long as possible. Time is recorded in seconds.
- Lateral Bridge Test:
The patient lies in a side-lying position with the lower arm flexed at 90° and forearm on the table. The upper arm is crossed over the chest. Lower extremities are extended
Measured: 3 week
Visual Analog Scale (VAS)
Pain levels will be evaluated using the Visual Analog Scale (VAS), ranging from 0 to 10. A score of 0 indicates no pain; 1-4 indicates mild pain; 5-6 indicates moderate pain; 7-10 indicates severe pain.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start30 Jul 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain (LBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups with a conventional therapy control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selvin BALKİ, Cumhuriyet University
- Investigators
- Balki, PhD, Study director, Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943898
- Sponsor's protocol ID
- SCU-FTR-SB-01
- Acronym
- 360° Breath
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effects of Core Stabilization and 360-Degree Breathing Exercises on Balance and Proprioception in Individuals With Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06943898
- Acronym / sponsor ID
- 360° Breath / SCU-FTR-SB-01
- Conditions
- Low Back Pain (LBP), Exercise, Core Stability
- Keywords
- core stability exercise, low back pain, exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a single-blind randomized controlled trial. Male and female patients aged 18-65 years with complaints of non-specific low back pain (NSLBP) lasting longer than 12 weeks will be included in the study. Participants will be randomly assigned into two parallel groups: control and intervention. The control group will perform core stabilization exercises five days a week for three weeks. In the intervention group, core stabilization exercises will be combined with 360-degree breathing exercises. To our knowledge, there is no randomized controlled trial investigating the effect of combining core stabilization with 360-degree breathing in individuals with NSLBP. The aim of this study is to examine the acute effects of combining 360-degree breathing techniques with core stabilization exercises on balance and proprioception in individuals with NSLBP.
Detailed description
Low back pain is a major health problem worldwide. Non-specific low back pain (NSLBP) is the most common form of back pain. The lifetime prevalence of back pain can reach up to 84%. Various non-pharmacological and non-invasive methods are used for back pain management. One such method is core stabilization exercises. Core stabilization exercises enhance trunk stability by activating the muscles around the spine and have the potential to improve balance in individuals with NSLBP. This may help overcome balance disorders associated with pain and contribute to safer movements in daily life activities. Breathing exercises, by activating the diaphragm muscle, support spinal stability and provide benefits in pain management. It is known that breathing supports trunk stability through its relationship with core muscles and strengthens balance mechanisms. Studies in this field show that stabilization exercises can provide short-term improvements, especially in balance. However, the combined effects of core stabilization and breathing exercises in individuals with NSLBP have not been fully investigated. Therefore, this study aims to investigate the acute effects of combining 360-degree breathing exercises with core stabilization exercises on balance and proprioception in individuals with NSLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups with a conventional therapy control group.
| Arm | Type | Receives |
|---|---|---|
| Control Group (Core Exercises) | Other | Other: Core EgzerciseCore Exercises Group |
| Intervention Group (Core Exercises + Breathing Exercises): | Other | Other: Core Exercises + Breathing ExercisesCore Exercises + Breathing Exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low back pain persisting for at least 3 months
- No neurological, rheumatological, or musculoskeletal system problems
Key exclusion criteria (7 listed)
- Individuals with neurological, vestibular, or serious orthopedic conditions that may cause physical disability
- Patients with back-leg or dorsolumbar pain due to lumbar disc protrusion or fracture
- Cancer patients
- Individuals with acute infections
- Individuals with respiratory system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core EgzerciseThe core exercise group will perform core stabilization exercises for a total of 15 sessions, five days a week for three weeks. Exercises will include pelvic tilt, bridge, dead bug, bird dog, mini squats on a balance board, and wall planks. The number of repetitions will be increased from 10 to 20, and plank duration will be increased from 30 seconds to 45 seconds. A 5-minute warm-up and cool-down session will be included. | Other | Control Group (Core Exercises) |
| Core Exercises + Breathing ExercisesThis group will perform core stabilization exercises combined with the 360-degree breathing technique, for a total of 15 sessions over three weeks (five days a week). "360-degree breathing" is a novel breathing method targeting deep and controlled inhalations into various regions of the body. Unlike traditional breathing exercises, 360-degree breathing ensures that all directions of the lungs are equally ventilated. | Other | Intervention Group (Core Exercises + Breathing Exercises): |
Primary outcome
• Proprioception Assessment
Time frame: 3 week
Proprioception will be evaluated using an inclinometric method. An inclinometer is usually placed and fixed at the L3-L4 segment of the lumbar spine. The patient will be asked to achieve and then reproduce a target position. The difference between the reference angle and the reproduced angle (position error) will be recorded as a measure of proprioceptive perception.
Y Balance Test (YBT)
Time frame: 3 week
The Y Balance Test (YBT) will be used to assess balance. Patients will remove their shoes and place the stance foot on the center footplate of the YBT platform. They will attempt to reach maximally with the opposite leg in three directions (anterior, posteromedial, and posterolateral), maintaining balance on the stance leg. Maximum reach distances will be recorded.
2 secondary outcomes
Core Muscle Endurance Assessment:
Time frame: 3 week
Visual Analog Scale (VAS)
Time frame: 3 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Balki, PhD study director
Sivas Cumhuriyet University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Egzercise and Core Exercises + Breathing Exercises in people with Low Back Pain (LBP) and Exercise, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator, PhD (+905065945067, sbalki@cumhuriyet.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Proprioception Assessment (time frame: 3 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.